NCT00520806

Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure

A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,161 (actual)
• Sponsor: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure

Detailed description

This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DRUG	Relaxin	Intravenous infusion for 48 h at 30 ug/kg/day
DRUG	Placebo	Intravenous infusion for 48 h

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2007-08-27
• Last updated: 2012-10-30

Locations

3 sites across 2 countries: United States, Israel